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Integration of Neutron Therapy in the Treatment Plan for Stage III Non-Small Cell Lung Cancer (NSCLC)

NCT01416961 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2012-08-22

No results posted yet for this study

Summary

This study is needed to assess the feasibility of integrating this therapy with current treatment regimens. If this study shows success a formal phase II test study to conduct feasibility will be the next step. The first dose level chosen for this study is 66Gy of radiation to the tumor between LET and standard photon therapy. This dose is the current standard of care for stage III . If this dose is found to be feasible then the dose of LET will escalate to the total dose of 74Gy.

Conditions

Interventions

RADIATION

Radiation Therapy

Concurrent chemo and photon radiation therapy will start within 7 days of completing neutron therapy. There will be a Day 1 of neutron therapy and a Day 1 of concurrent therapy.Photon radiation therapy will begin within 24 hours of the first cycle of chemotherapy and will be delivered 5 days per week, one fraction per day, in 1.8 Gy per fraction. High LET radiotherapy will be delivered in 1 NGy per fraction five days per week. High LET radiotherapy will be delivered first followed by combined chemoradiotherapy.

DRUG

Chemotherapy - Squamous Cell Histologies

Cisplatin 50 mg/m2 administered on days 1,8, 29, 36; Etoposide 50 mg/m2 administered on days 1-5 and then again days 29-33

DRUG

Chemotherapy - NSCLC other than squamous cell

Cisplatin 75 mg/m2 days 1,22,43; Pemetrexed 500 mg/m2 days 1,22,43

Sponsors & Collaborators

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Shirish M. Gadgeel, M.D. · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416961 on ClinicalTrials.gov